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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 14 FDA device recalls.

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DateProductReasonClassFirm
Aug 28, 2025 Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dex... A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpec... Class I Dexcom, Inc.
Jul 24, 2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... Class I Dexcom, Inc.
Jul 24, 2025 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... Class I Dexcom, Inc.
Jul 24, 2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... Class I Dexcom, Inc.
Jul 24, 2025 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... Class I Dexcom, Inc.
Jul 24, 2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... Class I Dexcom, Inc.
May 12, 2025 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & ST... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-00... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-01... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 5, 2025 Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G... A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops up... Class II Dexcom, Inc.
Jan 27, 2025 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... Class II Dexcom, Inc.
Jan 27, 2025 Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001... Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... Class II Dexcom, Inc.
Jan 27, 2025 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... Class II Dexcom, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.